Course Director: Carolyn Troiano

  • SKU: SEM3543

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The attendees will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry. We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products. This approach is amenable to the Agile software development methodology, which can be adapted for use in validation.

We will also discuss the important aspects of CSV and how to apply them in a new and modern technological environment. 


Day 1

• Identifying “GxP” Systems
• Current state of CSV approach based on FDA requirements
• Agile approach to System Development Life Cycle (SDLC)
• Pros and Cons of an Agile vs. Waterfall approach
• Cloud computing and Software as a Service (SaaS) systems
• Agile continuous validation approach
• Policies and procedures needed to support your validation process
• Q&A

Day 2

• CSA Gap Assessment
• Keys to a Successful CSA Implementation
• Documentation using a Waterfall or Agile approach
• Implementing CSA Across the organization – Avoiding disorientation
• Applicability of CSA Guidance to Data Integrity
• IT Supplier Assessments While Adopting CSA Principles
• Risk Assessment to optimize your validation approach
• Q&A

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